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Supportive care (decision making tool) for Breast Cancer
N/A
Recruiting
Led By Abenaa M Brewster
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a decision making tool to help patients with early stage breast cancer make decisions about their surgical options, including contralateral prophylactic mastectomy.
Who is the study for?
This trial is for English-speaking individuals newly diagnosed with early-stage breast cancer (DCIS or stage I-III) who haven't had previous breast cancers, bilateral mastectomies, known genetic mutations like BRCA1/2, or a strong family history of cancer.Check my eligibility
What is being tested?
The study is evaluating the effectiveness of a decision-making tool designed to help patients understand their surgical options and make informed choices about contralateral prophylactic mastectomy.See study design
What are the potential side effects?
Since this trial involves a decision aid and questionnaires rather than medical treatments, there are no direct physical side effects. However, participants may experience emotional or psychological impacts from discussing surgical decisions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability of the decision support tool
Changes in patient's knowledge of contralateral prophylactic mastectomy (CPM)
Reductions in decisional conflict about CPM
Trial Design
1Treatment groups
Experimental Treatment
Group I: Supportive care (decision making tool)Experimental Treatment2 Interventions
Patients use decision making tool during consultation with breast cancer surgeon and complete questionnaires before and after consultation.
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,986 Previous Clinical Trials
1,789,302 Total Patients Enrolled
148 Trials studying Breast Cancer
63,277 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,708 Previous Clinical Trials
40,932,714 Total Patients Enrolled
942 Trials studying Breast Cancer
1,543,966 Patients Enrolled for Breast Cancer
Abenaa M BrewsterPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had breast cancer in the past.You had surgery to remove both breasts as a preventive measure.You have a gene mutation that makes you more likely to develop breast cancer or a strong family history of cancer that puts you at high risk for developing breast cancer in the other breast.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive care (decision making tool)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unfilled slots for participants in this experiment?
"Affirmative. Clinicaltrials.gov records indicate that this medical experiment, which was initially posted on April 28th 2017, is actively recruiting participants. This trial requires 15 subjects to be sourced from a single site."
Answered by AI
What is the current sample size of this clinical investigation?
"Affirmative. The clinicaltrials.gov website indicates that, after being first posted on April 28th 2017 and last edited November 11th 2022, this trial is still in need of 15 participants at a single location."
Answered by AI
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